Quality of Life and Sjögren Syndrome

Grupo de Investigação em Bioquímica e Biologia Oral

Status and phase: Completed; Phase 4

Conditions: Xerostomia; Sjogren's Syndrome; Quality of Life; Hyposalivation

Treatments: Drug: Citric Acid based Mouthwash; Drug: Xeros

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03578900

QL2015

Details and patient eligibility

About

The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires.

The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• unstimulated whole saliva secretion rate < 0.1 ml/min
• stimulated whole saliva secretion rate > 0.2 ml/min
• above 18 years of age
• Primary Sjogren Syndrome diagnostic according to the European-American Consensus Group

Exclusion criteria

• wearer of complete dental prosthesis
• those who were pregnant or lactating
• non-speakers of Portuguese.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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289 participants in 5 patient groups

Xeros Group - Lozenge

Experimental group

Description:

Application of Xeros system for 15 days. Lozenge (Malic acid 28.56 mg, Xylitol 421,98 mg, Sodium fluoride 0.55 mg) or Spray (Malic acid 1%, Xylitol 10%, Sodium fluoride 0.05%) 4 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. Effects of lozenge on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a ph electrode at predetermined times during a 20 minute period.

Treatment:

Drug: Xeros

Mouthwash group

Active Comparator group

Description:

Application of citric acid based Mouthwash (0,33% citric acid) for 15 days four times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. Effects of mouthwash on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a pH electrode at predetermined times during a 20 minute period.

Treatment:

Drug: Citric Acid based Mouthwash

Xeros Group - Mouthwash

Experimental group

Description:

Application of Xeros system for 15 days. Mouthwash (Betaine 1.33%, Xylitol 3.30%, Sodium fluoride 0.05%, Allantoin 0.10%) 2 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.

Treatment:

Drug: Xeros

Xeros Group - Gel

Experimental group

Description:

Application of Xeros system for 15 days. Gel (Betaine 1%, Aloe Vera 0.05%, Xylitol 10%, Sodium Fluoride 0.0033%) before bed. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.

Treatment:

Drug: Xeros

Xeros Group - Toothpaste

Experimental group

Description:

Application of Xeros system for 15 days. Toothpaste (Betaine 4%, Xylitol 10%, Sodium Fluoride 0.33%, Allantoin 0.10%) 3 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.

Treatment:

Drug: Xeros